Alliance180 Program for Trauma

Recruiting at 1 trial location

Overseen By Keri J Heilman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Completed Alliance180 Program

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of the Alliance180 Program (an Equine-Assisted Therapy Program) on the physical and mental well-being of adults who are or were US Veterans, First Responders, or Front Line Healthcare Workers. The researchers aim to assess how the program influences feelings of safety, mental health (such as depression, anxiety, and trauma response), and the body's automatic stress responses. Participants will complete surveys about their well-being and mental health before and after attending the program. This trial suits those currently experiencing trauma-related symptoms who have not previously completed the Alliance180 Program. As an unphased trial, it offers a unique opportunity to explore innovative therapy methods and contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Alliance180 Program is safe for participants?

Research has shown that the Alliance180 Program is generally safe for participants. In a small study with 38 healthcare workers, the program was well-received, and participants reported no major negative side effects.

Although detailed safety information remains limited, the program's focus on peer support and activities with horses suggests it poses low risk. This type of therapy typically aims to provide emotional and psychological support rather than medical treatment, often resulting in fewer physical side effects. However, further research is needed to confirm its safety for everyone.

For those considering joining the trial, the initial findings are encouraging. Nonetheless, discussing any concerns with a healthcare provider before participating is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike many traditional treatments for trauma, which often rely on long-term therapy and medication, the Alliance180 Program is unique because it offers an intensive, three-day experience designed to rapidly address trauma symptoms. This program stands out by utilizing a concentrated, short-term approach that aims to deliver faster relief and recovery compared to conventional methods. Researchers are excited about the potential for the Alliance180 Program to provide quicker, more effective outcomes for trauma patients, potentially reducing the need for prolonged treatment durations.

What evidence suggests that the Alliance180 Program is effective for improving physical and psychological well-being in adults who are/were US Veterans, First Responders, and/or Front Line Healthcare Workers?

Research has shown that the Alliance180 Program, which participants in this trial will attend, includes therapy with horses and may aid in trauma recovery. One small study with healthcare workers found that a short, four-hour session safely boosted their resilience and well-being. Therapy with horses has also shown promise for veterans, with studies suggesting it effectively supports mental health. While more research is needed to fully understand its benefits, these early findings encourage those dealing with trauma and stress-related issues. ^{1 2 3 5 6}

Who Is on the Research Team?

Keri J Heilman, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for US Veterans, First Responders, and Front Line Healthcare Workers who have experienced trauma or stress. Participants must be adults willing to report on their well-being and mental health before and after the Alliance180 Program at various intervals.

Inclusion Criteria

Enrollment in an upcoming Alliance180 Program (limited to adults who currently or formerly serve as US Veterans, First Responders, and/or Front Line Healthcare Workers and are currently experiencing symptoms related to trauma exposure)

Exclusion Criteria

Individuals who have previously completed the Alliance180 Program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Research Session

Participants complete self-report measures of demographic information, perception of safety, trauma experience, autonomic reactivity, anxiety/depression, and purpose in life

1 day

1 visit (virtual)

Alliance180 Program

Participants attend the 3-day Alliance180 Program, including the Transformative Equine Experience

3 days

Post-intervention Research Sessions

Participants complete self-report measures of perception of safety, trauma experience, autonomic reactivity, anxiety/depression, and purpose in life at 1 week, 1 month, 3 months, and 6 months after the program

6 months

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alliance180 Program

Trial Overview The Alliance180 Program's impact on physical and psychological well-being is being tested. The study will assess changes in feelings of safety, autonomic functioning, depression, anxiety, and trauma response over time after completing the program.

How Is the Trial Designed?

Group I: Alliance180 Program Experimental Treatment 1 Intervention

Participants will attend the 3-day Alliance180 Program.

Alliance180 Program is already approved in United States for the following indications:

Approved in United States as Alliance180 Program for:

• Post-traumatic stress disorder (PTSD) prevention
• Suicide prevention
• Trauma response management

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

ALLIANCE180, INC

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

Equine-assisted psychotherapy (EAP) significantly improved the mental health of children, as shown by a rise in the Children's Global Assessment of Functioning (GAF) scores from a mean of 54.1 to 61.7 after an average of 19 sessions, indicating effective intervention for behavioral and mental health issues.

The study found that younger children and those with a history of physical abuse and neglect experienced the greatest improvements, suggesting that EAP may be particularly beneficial for these vulnerable groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine-assisted psychotherapy: a mental health promotion/intervention modality for children who have experienced intra-family violence. Schultz, PN., Remick-Barlow, GA., Robbins, L.[2007]

The pilot study involving 38 healthcare workers demonstrated that a four-hour equine-assisted resiliency psychotherapy intervention was safe and led to short-term improvements in psychological flexibility and positive affect, while reducing negative affect.

Despite these benefits, the intervention was underutilized, and there was no significant change in overall resiliency, indicating a need for future studies to enhance participation and explore the effectiveness of such interventions more rigorously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A replication study of a psychotherapy incorporating horses resiliency intervention for healthcare workers. Marchand, WR., Sullivan-Sakaeda, L., Lackner, R., et al.[2023]

Equine Facilitated Psychotherapy (EFP) shows promise for helping traumatized youth, particularly those with complex trauma histories, as highlighted by the development of a new model called Equine Facilitated Therapy for Complex Trauma (EFT-CT).

The article presents three case studies that utilize both clinician observations and longitudinal psychosocial measures, suggesting that EFT-CT may effectively integrate EFP practices within an established trauma treatment framework, potentially improving outcomes for affected youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine Facilitated Therapy for Complex Trauma (EFT-CT). Naste, TM., Price, M., Karol, J., et al.[2023]

The newly developed eight-session equine-assisted therapy (EAT) protocol for PTSD was found to be safe and well-accepted by military veterans, with no reported adverse events and high treatment completion rates.

Preliminary results indicated significant reductions in PTSD and depressive symptoms post-treatment, with medium to large effect sizes, although these benefits did not persist at the 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings. Arnon, S., Fisher, PW., Pickover, A., et al.[2021]

A new standardized assessment tool for equine-assisted therapy was developed based on the International Classification of Functioning, Disability and Health (ICF) framework, which includes a general module and three specialized submodules, tested with 116 participants across six therapy centers in Germany.

The tool demonstrated good to excellent reliability and supports a structured approach to measuring the effects of equine-assisted therapy, potentially enhancing its integration into the international healthcare system and enabling evidence-based outcome measurement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an ICF-based assessment tool for equine-assisted therapy: model structure and reliability. Stolz, I., Tillmann, V., Anneken, V., et al.[2023]

Equine-Assisted Therapy (EAT) has been shown to significantly improve exercise tolerance and quality of life in individuals with various health conditions, based on a systematic review of 23 randomized clinical trials.

EAT also positively affects mobility and interpersonal interactions, indicating its potential as a beneficial therapeutic intervention for people with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of equine-assisted therapy on the functionality of individuals with disabilities: systematic review and meta-analysis. Prieto, A., Martins Almeida Ayupe, K., Nemetala Gomes, L., et al.[2022]

A study involving 63 veterans with PTSD showed that an 8-session group Equine-Assisted Therapy (EAT-PTSD) resulted in significant reductions in PTSD and depression symptoms, with improvements lasting up to 3 months after treatment.

The therapy was well-accepted, with only 8% of participants withdrawing, indicating its feasibility and potential as a safe intervention for veterans seeking help for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equine-Assisted Therapy for Posttraumatic Stress Disorder Among Military Veterans: An Open Trial. Fisher, PW., Lazarov, A., Lowell, A., et al.[2021]

A 6-week equine-assisted psychotherapy (EAP) program for veterans with PTSD showed similar improvements in PTSD symptoms and resilience compared to standard therapy, suggesting it may be an effective alternative treatment.

While both groups experienced significant reductions in PTSD symptoms and increases in resilience, there was no statistically significant difference in the outcomes between the EAP and control groups, indicating that EAP could be as beneficial as traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder. Burton, LE., Qeadan, F., Burge, MR.[2020]

Equine-assisted interventions (EAI) have shown positive effects on various health aspects in older adults, including improvements in physical balance, gait, and muscular strength, as well as enhancements in quality of life and physiological measures like hormonal activity.

Out of 13 studies reviewed, EAI demonstrated significant benefits across physical, psychological, and physiological health domains, suggesting it could be a valuable non-pharmacological treatment option for promoting well-being in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of equine-assisted interventions on older adults' health: A systematic review. Badin, L., Alibran, É., Pothier, K., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-trauma-and-stressor-related-disorders-6-2024-38d0f

Alliance180 Program for Trauma The pilot study involving 38 healthcare workers demonstrated that a four-hour equine-assisted resiliency psychotherapy intervention was safe and led to short- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06451523?cond=Trauma%20and%20Stressor%20Related%20Disorders&aggFilters=status:rec&rank=1

Effects of "Alliance180 Program" on Well-Being An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. alliance180.org alliance180.org/the-rescue-pilot-and-the-horse

THE RESCUE PILOT AND THE HORSE Over the years, the Nevins/Squier program evolved until today, called Alliance180, it also includes traumatized first responders and frontline health care ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10654975/

Equine-assisted interventions for veterans with ... Equine-assisted intervention therapy has been shown to be effective, but further research is merited, in order to focus on the specific details ...

5. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLVspLrShR0lHycw4xMDUxMDA1NFLS0bWEARxMCz0jEwtjY0MdQ3MTC3NjMwMw0FHKSy4xMDWzMDc0MlaKBQDTrBSM

Save Selected The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are/were US ...

6. alliance180.org alliance180.org/

Alliance180 | Suicide Prevention for Veterans and First ... Alliance180 is a peer-to-peer, purpose-driven program that aims to prevent suicide for fellow Veterans and First Responders facing the effects of trauma ...